Gynaecological device

ABSTRACT

A gynaecological device constituting a vulvar compress of oblong shape with a rim of absorbent material, comprises a support part of a flexible and impermeable material and another part forming a longitudinal bulge formed of a material of the gauze type matching the anatomical contours. The bulge can enclose a medicinal substance, impregnating the gauze, or housed in a compartment bounded by the gauze, for instance, in the form of a gynaecological suppository. The device may comprise a flexible and impermeable envelope, forming a pocket, in which are enclosed, before placing in operation, a medicament or a tampon to be applied, and arranged so that it comprises a first part adapted to cover the hand of the user at the moment of use and a second part constituted by an invagination inside of which a tampon is at least partially housed. A guide element for the positioning of the tampon or medicament may be included.

United States Patent 1191 Alemany 14 1 Dec. 31, 1974 GYNAECOLOGICAL DEVICE [76] Inventor: Raymond Alemany, 2, rue Gervex, Pnmary Exammer 9 Howell Paris (176), France Attorney, Agent, or Firm-Larson, Taylor & Hmds [22] F11ed. Sept. 8, 1972 [57] ABSTRACT [2]] Appl' No" 287,469 A gynaecological device constituting a vulvar com- I press of oblong shape with a rim of absorbent mate- [30] Foreign Application Priority Data rial, comprises a support part of a flexible and imper- Sept. 17, 1971 France 71.33617 meeble material and another P forming a lohgiwdinal bulge formed of a material of the gauze type [52] us. Cl 128/260, 128/128, 128/263, matching the anatomical Contours T ulg an en- 128/290 close a medicinal substance, impregnating the gauze, 51 1111.01 A6lm 31/00 or housed in a Compartment bounded y the gauze, [58] Fieldof Search 128/127, 260, 263, 270, for instance, in the form of e gynaecological p 128/271, 285, 128, 138, '251, 168, 289 291 tory. The device may comprise a flexible and impermeable envelope, forming a pocket, in which are en- [56] References Cit d closed, before placing in operation, a medicament or a UNITED STATES PATENT tampon to be applied, and arranged so that it com- 066 356 H1913 Woodward 128,128 prises a first part adapted to cover the hand of the 1]23994 H1915 08/128 user at the moment of use and a second part consti- 231041423 1/1938 Hughes l 28/290 H by invaginatlon 9 of wh'ch a tamPO 2,331,355 10/1943 Strongson 128/290 R least'partially housed A guide element for the P 3,225,765 12/1965 Mosieretal l28/290H honing 0f the tampon 0r medicament y be 3,262,450 7/1966 Elias 128/270 cluded. 3,575,174 4/1971 Mogor 128/290 R 3,594,468 7/1971 Saurino et a1 128/270 9 Clam", 6 Drawmg Flgures l l PATENTED BEDS 1 I974 sum 10F 1 GYNAECOLOGICAL DEVICE Theinvention relates to a gynaecological means or device, that is to say means used in the field of treatment relating to the female genital organs.

These treatments, which relate to the application of certain medicaments for the 'virlvO-vaginal area or the use of menstrual tampons pose not only problems of hygiene and of comfort during manual positioning of the tampons or medicaments, but also, in the case of v'ulvar medicaments, problems arising from the maintenance in position of said medicaments.

It is a particular object of theinvention to provide a solution to these problems and to provide means of the I portion forming a support which. is formed of a flexible and impermeable material and another portion forming a longitudinal bulge or swelling formed of a material of the gauze type, matching the anatomical contours and if necessary impregnated with a medicinal substance which can also be housedin a compartment bounded by the 'gauzeor be in the form of an ovule.

According to another aspect of the invention, the abovesaid gynaecological means comprise a'flexible andimpermeable envelope, forming a pocket in which are enclosed, before the placing in operation, the medicaments or the tampon to be applied, this pocket being arranged so that it comprises a first portion which, at the moment of use, can cover the hand of the user and a second portion constituted by an invagination inside of which the tampon is at least partially housed, a guide element for the introduction or the placing'in position of the medicament or the tampon being, preferably, also-provided.

The invention consists, apart from the abovesaid features, of certain other features which are preferably used at the same time, but of which certaincan be used independently and which will be more explicitly, considered-below.

The invention will in any casebe better understood by means of the additional d'escriptionwhich follows, aswell as of the accompanying drawings, which description and drawings relate, to preferred embodiments, given of course purely by way of illustrative but nonlimiting example.

In the drawings:

FIG. I is a diagrammatic view showing the elements entering into the constitution of the means according to the invention within the scope of a first embodiment relating to menstrual tampons.

FIGS. 2, 3 and 4 show, respectively, in plan view before use in elevation and in plan view after being deformed, in more detail, one of the elements entering stage of the placing in position and in plan view after positioning, yet another embodiment of means according to the invention relating to vulvo-vaginal medicaments.

FIG. I3 shows in plan view a modification of the embodiment'illustrated by FIGS. 10 and I2.

FIGS. 14 and I5 are sections along the lines XlV-XIV and XV-XV of FIG. 13 and show means according to the invention after the placing in position on the user. v

FIG. 16, lastly, shows in diagrammatical partial view a modification of the means shown in FIG. 15.

According to the invention and more especially according to those of its types of application as well as according to those embodiments of its'various parts, to which it would seem that preference should be given, in order to manufacture gynaecological means of the type concerned, procedure is as follows or in analogous manner. a 1

These means are made to comprise:

'on one hand an envelope, formed of a supple and impermeable material, especially of a flexible plastics material for example of the polyethylene or thin latex type, of which the shape is such that it can constitute a pocket or purse in which is enclosed, before the placing in operation, a menstrual tampon or a medicament to be applied, and,

on the other hand, preferably a guide element for the introduction or the placing in position of the tampon or the medicament.

The abovesaid pocketor purse is arranged so that it can cover the hand of the user at the moment of use and must enable the realisation of positioning or introduction operations under the best possible conditions of hygiene. I

In the embodiment shown in FIG. 1 and more particularly. intended for the introduction of menstrual tampons, the abovesaid pocket is denoted as a whole by I. This pocket comprises a portion la playing, at the moment of use, the role of protector for the hand of the user, the portion 1b constituted by an invagination inside of which is housed, at least partially, a tampon 2 provided with its extraction cord- 3.

The pocket 1 is formed from a sheet of plastics material, circular or rectangular, in the unfolded position (not shown) in the centre of which the abovesaid invagination is arranged.

The dimensions, both longitudinal and transverse, of the invagination are such that they enable the insertion of an index finger; saidinvagination, being adapted to the tampon in inactive position, then forms folds 4.

The pocket 1, once the tampon 2 has been introduced into the invagination, is closed as shown in FIG.

1, for example by welding at S, a cord 5 enabling simplified opening by tearing. Instead of the cord, there can be provided a zone of leaststrength.

To facilitate the introduction of the tampon 2, there can be provided at its free end a layer 6 of lubricant selected so that it is not'absorbed by the constituent cotton of the tampon.

In addition to the pocket I, means according to the invention comprise preferably the abovesaid guide element which, in the case of the embodiment shown, is constituted by an oval or rectangular oblong ring 7, shown in FIGS. 2 and 3 and'bounding an elongated hole 8. t

As seen, this ring comprises four flats 7a, 7b, 7c and 7d which facilitate its manipulation. The constituent material of the ring is semi-rigid and elastic, enabling its deformation under the influence of pressure along the arrows 9a and 9b exerted at the level of the flats 7a and 7c; recourse could for example be had to synthetic material of the polypropylene or polyethylene type such as that known by the trademark Polythene." The ring then takes the shape illustrated byFIG. 4, the sodefined hole 8 then being substantially circular and of dimensions such that it permits the passage of the index finger.

To cause it to play the role of guide element, the ring 7 is placed, once it has been brought into the position illustrated by FIG. 4, on the invagination lb (in discontinuous line, FIG. 1). The pressure exerted along the arrows 9a and 9b is then relaxed, the ring coming to grip the invagination and the tampon, thus making fast these elements to one another. By means of the ring gripped on the tampon, it becomes easy to guide the latter. It suffices to seize the ring between the thumb and the index finger placed on the flats 7b and 7d, to open the pocket 1 by pulling on the cord and to fold back the pocket on the hand along the arrows 10a and 1012, as shown in FIG. 6. The free end of the tampon is then introduced into the vaginal passage as seen in FIG. 6 on which the contours of the latter have been shown diagrammatically at 11. The step following the introduction consists of bringing the ring to the position of FIG. 4 as seen in FIG. 7 (pressure along 90 and 9b, exerted on the flats 7a and 70), then pushing (arrow F) the tampon with the index of the other hand to bring it into the vagina as shown in FIG. 8. The invagination 1b has a sufficient length for the latter operation due to the folds 4.

It will be easily seen that, during the whole of these operations, both hands remain perfectly protected.

The operation being completed, the pocket 1 is discarded whilst the ring 7, also protected by the pocket, can be used again.

It suffices, consequently, to provide only a single ring in the box of tampons.

In the modification illustrated by FIG. 5, the guide element is constituted by a part of generally conical shape, for example a conical tube 12 of flexible plastic material, which can be fixed by welding at the level of its large base to the inner surface of the pocket, at the height of the edge of the invagination. At the level of its small base, the tube 12 can be provided advantageously with a layer 6 of lubricant facilitating introduction. The other features of this embodiment and its method of use are identical with those of the preceding embodiment, the index of the free hand passing, at the moment of introduction, through the tube 12.

As regards the part 12, it is indicated that it can be constituted also, as shown in FIG. 16, by a ring 12a, gripped by the pocket at the level of the edge of the invagination and comprising at least two sheathing strips 12b and l2c'applied against the portion of the tampon which is situated inside the pocket 1. The asembly of the part 12 then forms a sort of minispeculum. The extraction cord passes into the interstice comprised between the two strips. In this regard it is pointed out that, in the case of the conical tube provided above, it is advantageous to provide a hole in the wall of the latter for the passage of the cord.

The embodiment of the gynaecological means according to the invention, shown in FIG. 9, is more particularly concerned with a device for the introduction of semi-liquid vaginal medicaments, in the form of cream, foam or gel, contained inside a cannula 13 of flexible material, for example of the polyethylene type, of a generally conical shape, whose point 13a is perforated with holes l3b. The holes 13b serve for the passage of a medicinal cream 14 contained inside the cannula.' r

The means according to the invention comprise, as previously, a pocket or purse 1 and a cylindrical guide element 15 advantageously borne by the canula 13 as shown. The element 15 is constituted preferably by a reinforcement of the base of the cannula, flats facilitating the gripping being provided.

The pocket 1 is composed of a portion la, similar to the corresponding portion of the preceding embodiments, and of a portion 1c in the form of a glove finger folded back on itself by means of folds l6 and of which the end is placed in the opening of the cannula in contact with cream 14. Advantageously, there is provided at the end of the portion 1c a rigid part 17 whose shape which is shown in FIG. 9 is such that it can be adapted into theend of the cannula and enable the expulsion of all the cream 14 through the holes 13b, as will be explained below.

The pocket 1 is fixed, forexample by welding, to the element 15, as seen at 18. It can also be fixed by means of a simple narrowing of the pocket at this level.

Before use and with the object of hygiene, the ring 15 and the portion 10 areprotected by a removable diaphragm 19. V

It will be advantageous to cover the end of the cannula with a removable protective diaphram to avoid the flow of the cream before use.

The placing in operation is as follows: first of 'all the diaphram 19 is removed, the ring 15 is seized between finger and thumb, the pocket 1 is opened by drawing on the cord 5 and the portion la is folded back on the hand. The diaphram protecting the end of 'the cannula is removed.

The cannula 13 is then introduced into the vaginal orifice. The index fingerof the other hand is introduced into the glove finger constituting the portion 1c of the pocket 1, and by pushing the part 17 just within the end of the cannula, expulsion of the cream 14 through the holes 13b is caused.

Advantageously, the part 17 comprises a rim 17a means according to the invention, shown in FIGS. 10,

11 and 12.

In the case of this embodiment, the tampon 2 is replaced bya gynaecological ovule 20.

As seen in FIGS. 10 and 12, the means according to the invention again comprise a pocket 1 and a guide element constituted by a ring 27 whose constitution emerges from FIG. 12 and which enables the pocket to be gripped at the level of the jaws 30a/30b and 31a/3lb, without crushing the ovule which is housed in a hole 32.

The pocket 1 is this time composed of a portion 1d and a fold or diverticulum le-in which, one of the ends of the ovule 20 which passes through the hole 32, is housed. The assembly ofthe parts 1d and leis such that in the spread-out condition, as shown in FIG. 12, the pocket is in the shape of a rectangular compress bounded by a peripheral strip 21 of absorbent material.

By way of example, it is indicated that the dimensions of the elements which have just been described can be as follows with reference to FIG. 12:

whole of the pad: length I2 to lo cm width 6 to 8 cm central gauze'compress: length 6 to 8 cm width 4 to 6 cm absorbant peripheral bulge: length 10 to mm thickness mm In additional to the ovule 20, the pocket 1 encloses a compartment 22 bounded by gauze 23 and enclosing the medicinal cream 24, the shape of this compartment, which will be clearly apparent from' FIG. 12,

7 being such that it forms a pad which matches the contours of the vulvar zone, the hole constituting consequently, in the spread-out condition, a vulvar compress.

The ring 27 is placed on the portion 1e so that it indicates the anterior-posterior direction thus facilitating the placing in position.

As previously, the pocket is closed to form a purse enclosing the ovule and the cream, but the opening cord 5 is placed so that its action enables the compress to be cut at the outer edge of the strip 21 which advantageously comprises two tongues 33a and 33b which will be more explicitly considered with regard to the FIG. 15.

The placing in operation is as follows:

The ring 27 is gripped between the finger and thumb which are applied at 27b and 27d. The cord 5 is withdrawn and the compress thus opened. By means of the ring, the compress is applied in the anterior-posterior direction indicated by the large dimension of the ring and by the large dimension of the compartment 22 against the vulvar region. After the introduction of the end of the ovule into the vaginal orifice, the ring 27 is withdrawn by means of compression along 29a, 2%; the portion 1e resumes its normal position through the elasticity of the constituant material of the pocketl, then due to pressure along the arrow 26, FIG. 11, the ovule is completely introduced into the vaginal passage and the pad formed by the compartment 23 becomes matched with the vulvo-vaginal anatomical contours 28, the medicinal cream 24 being expelled from the compartment 23.

The compress thus placed in position can easily be held by the garments, the absorbant peripheral strip 21 effecting protection againstany excess of medicament or excretion; the strip 21 can be formed for example of compressed hydrophilic cotton.

The advantage of the tongues 33a and 33b results from FIGS. 11 and 15; in fact, these tongues, by cooperating for example with the elastic 41 of the slip 42 of the person using it, are held in the genito-crural furrow 43 and thus ensure the holding in position of the compress. The tongues 33a and 33b are advantageously formed of flexible gauze or of a soft fabric to' render contact with the skin as comfortable as possible.

Of course, it is possible to produce the compresses which have just been described without giving them an ovule 20. In this case, the ring 27 does not necessarily include a hole 22, but only the jaws to grip the pocket atthe anterior-posterior crease which thus confers on the assembly a suitable rigidity. The ovule could then be replaced by an excess thickness of gauze constituting the anterior-posterior pad. This local thickening will enable better contact with the mucous membranes to be treated.

It is also possible to contemplate the use of the compress thus constituted without having recourse to a guide ring, the orientation then being given by a large dimension of the compress.

It is also possible to produce compresses directly in the shape resulting from FIG. 12, the active surface of the compress then being protected by a diaphram before use.

In the case of the embodiment shown in FIGS. 13 to 15 (the common elements with the-embodiment of FIGS. 10 to 12 are noted by the same reference numerals), the compress preserves the general shape shown in FIG. 12 but is of a more oval configuration by increasing the length, so that, as seen in FIG. 14, its front end 14a is presymphysary (that is to say situated in front of the pubic symphysis 36) and its posterior end 40b is para-anal.

The dimensions of the compress are, within the scope of this embodiment, from 8 to 10 cm in the direction of the width and from 12 tol8 cm in the direction of the length.

Thus as is evident especially from FIGS. 14 and 15, the compress is generally conch-shaped, that is to say as a whole, concave upwardly both in the frontal plane and in the saggital plane and this, by lifting the circumferential edge covered with its absorbant beading 21. The compress proper 37, which is formed of gauze which may or may not be impregnated with medicament, is alone in contact with the mucuous membranes and. advantageously has the shape of a longitudinal beading 38 matching well the anatomical contours; this anterior-posterior beading is raised over its whole length and thus bounds two lateral cavities 38a and 38b, which gives in section the appearance of the upper portion of a heart. To confer on the compress proper the shape which has just been described the plastics support 39 of said compress proper can be made to comprise (contrary to that shown in FIG. 15, it is possible to arrange that this is the plastics layer 39a of the gauze 37 which constitutes the support 39 then being eliminated) an excess thickness constituting an axial ridge which must be sufficiently rigid so that the compress proper permanently has the abovesaid anteriorposterior beading. The relief will be at a maximum at 400 at the level of the vulva orifice in order to hold the constituant gauze of the compress 37 in contact with the mucuous membranes to be treated.

It is also possible tomake the compress proper comprise a removable strengthening element, for example in the form of rigid whale bone, constituted by synthetic material of the type known under the trademark polythene; in the figures, the whale-bone constituting the reenforcing element has been shown diagrammatically at 40. This reenforcment element in the shape of a whale-bone is of circular or oval cross section and has a diameter of several milimetres. It in cludes at its forward portion a flattened zone 44a (for example in the shape of a fork or triangular spatula) which is applied to the surface of the body in the presymphysary region thereby facilitating thus the holding in position of the whale-bone. To retain this reenforcing element at the lower surface of the compress, there may be provided at the front A and rear B ends of the latter denoted respectively at 44c and 44b in which the front and rear ends of the reinforcing elements are housed. The latter is modeled so as to mate at a distance an anatomical contours so as only to affect upward pressure opposite the vulvo-vaginal orifice at 40a and consequently lift the support 39 (when one is provided) and the constituent gauze of the compress proper 37 which will thus remain in contact with the mucuous membrane to be treated whatever the position of the patient.

. Given that, in the latter embodiment, the reinforcing element in the shape the whale-bone is removable, the user will be able to use thecompress as necessary after having drawn the said reinforcing element. The latter is advantageously formed of a deformable material such as an aluminum-based alloy which preserves the shape which is conferred upon it by deformation and which the user will be able to model before use in order to arrange that the constituant gauze of the compress proper is in contact at the level of the mucuous membranes to be treated at a zone which will be selectable by the user as a function of his anatomical configurat1on.

The surface of the support 39 is in contact with the clothing can be rendered rough (reliefs, asperities) thus resisting sliding.

It is finally possible to place at the disposal of the user a slip specially devised for carrying the abovesaid compresses. This slip comprises at the level of the crotch, a housing formed for example by redoubling the constituant material of the slip (that is to say for example of the nylon) and intended to receive the compress.

' The corresponding portions of the slip and of the compress could be provided with self-adherent or selfadhesive strips enabling the use of the slip several times.

This being the case and whatever the embodiment adopted, there is thus provided gynaecological means whose characteristics emerge sufficiently from the foregoing for it to be unnecessary to dwell further on this subject and which have numerous advantages, especially that of enabling:

preparation in a completely sterile package of menstrual tampons or of medicinal products for vulvovaginal purposes,

simple technique of manufacture hygienic use since the hands are constantly and completely protected during the various applications,

in its form tampon introducer, direct control of the perfect positioning of the tampon by the protected index finger,

in its vulvar compress form, a complete, sterile and impermeable dressing.

As is self-evident and as emerges already from the foregoing, the invention is in no way limited to those of its types of application, nor to those embodiments of its various parts, which have been more especially indicated; it encompasses, on the contrary, all modifications.

[ claim:

I. Gynaecological device constituting a vulvar com press of oblong shape, said device comprising a peripheral rim of absorbent material, a continuous substantially oblong support sheet of a flexible and impermeable material bounded by said rim, and a sheet of a material of the gauze type forming an inner lining on said support sheet, said lining being adapted to match the anatomical contours and said rim constituting the only absorbent part of the device.

2. Gynaecological device according to claim ll, wherein said inner lining forms a longitudinal bulge in said oblong shape.

3. Gynaecological device according to claim 2, wherein said bulge encloses a medicinal substance.

4. Gynaecological device according to claim 3, wherein said inner lining is impregnated with the medicinal substance.

5. Gynaecological device according to claim 3, wherein said medicinal substance is housed in a compartment bounded by the inner lining.

6. Gynaecological device according to claim 3, wherein said medicinal substance is in the form of a gynaecological suppository.

7. Gynaecological device comprising a pocket of impermeable plastics material inside of which is housed an oblong compartment bounded by a substance of the gauze type and enclosing a medicinal cream, said pocket being arranged so that in the opened-out state it forms a support sheet and is in the shape of a rectangular or oval, oblong compress, as defined in claim 18, the compartment being oriented in the direction of greatest length.

8. Gynaecological device, comprising a pocket of impermeable plastics material inside of which is housed an oblong compartment bounded by a substance of the gauze type and enclosing a medicinal cream, said pocket being arranged so that in the opened-out state it forms a support sheet and is in the shape of a rectangular or oval, oblong compress, the compartment being oriented in the direction of greatest length, wherein the support sheet comprises a ridge of material deformable and flexible but sufficiently strong to mate the longitudinal bulge to the anatomical contours.

9. Gynaecological device according to claim 8, comprising a reinforcing element of the removable whalebone type cooperating with the support sheet and formed of a deformable and malleable material capable of taking up by deformation and of preserving, a configuration due to which it applies the constituent gauze of the compress proper against the anatomical areas to be treated. 

1. Gynaecological device constituting a vulvar compress of oblong shape, said device comprising a peripheral rim of absorbent material, a continuous substantially oblong support sheet of a flexible and impermeable material bounded by said rim, and a sheet of a material of the gauze type forming an inner lining on said support sheet, said lining being adapted to match the anatomical contours and said rim constituting the only absorbent part of the device.
 2. Gynaecological device according to claim 1, wherein said inner lining forms a longitudinal bulge in said oblong shape.
 3. Gynaecological device according to claim 2, wherein said bulge encloses a medicinal substance.
 4. Gynaecological device according to claim 3, wherein said inner lining is impregnated with the medicinal substance.
 5. Gynaecological device according to claim 3, wherein said medicinal substance is housed in a compartment bounded by the inner lining.
 6. Gynaecological device according to claim 3, wherein said medicinal substance is in the form of a gynaecological suppository.
 7. Gynaecological device comprising a pocket of impermeable plastics material inside of which is housed an oblong compartment bounded by a substance of the gauze type and enclosing a medicinal cream, said pocket being arranged so that in the opened-out state it forms a support sheet and is in the shape of a rectangular or oval, oblong compress, as defined in claim 18, the compartment being oriented in the direction of greatest length.
 8. Gynaecological device, comprising a pocket of impermeable plastics material inside of which is housed an oblong compartment bounded by a substance of the gauze type and enclosing a medicinal cream, said pocket being arranged so that in the opened-out state it forms a support sheet and is in the shape of a rectangular or oval, oblong compress, the compartment being oriented in the direction of greatest length, wherein the support sheet comprises a ridge of material deformable and flexible but sufficiently strong to mate the longitudinal bulge to the anatomical contours.
 9. Gynaecological device according to claim 8, comprising a reinforcing element of the removable whale-bone type cooperating with the support sheet and formed of a deformable and malleable material capable of taking up by deformation and of preserving, a configuration due to which it applies the constituent gauze of the compress proper against the anatomical areas to be treated. 